Online Resources

Current Good Manufacturing Practice (cGMP)

Introduction: US FDA provides the latest regulatory updates and guidance documents for global cGMP compliance requirements.

Important regulations:

• 21 CFR Part 210 (Good Manufacturing Practice for Pharmaceutical Manufacturing)

• 21 CFR Part 211 (cGMP requirements for drug manufacturing, handling, and storage)

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Link: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

Introduction: Covering the GMP standards of the European market, highly consistent with PIC/S specifications.

Important Chapters:

• EU GMP Guidelines - Part I (Pharmaceuticals)

• EU GMP Guidelines - Part II (API)

• Appendix (e.g. Appendix 1 is a guide to sterile product production)

Link: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en?utm_source=chatgpt.com

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Introduction: Highly consistent with EU GMP, applicable to pharmaceutical manufacturing and equipment requirements in multiple markets.

Adopted by Taiwan TFDA, Canada, Australia and other national drug regulatory agencies.

Link: https://picscheme.org/en/publications?tri=gmp#zone

International Council for Harmonization (ICH)

Important Guidelines:

• ICH Q7: Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients (API).

• ICH Q8, Q9, Q10: Involving process development, risk management, and quality systems, and closely related to cGMP.

Link: https://www.ich.org/

Taiwan TFDA - GMP Resources

Introduction: Taiwan's GMP regulations refer to PIC/S and ICH standards and are applicable to local pharmaceutical companies and medical device manufacturers.

Link: https://www.fda.gov.tw/TC/index.aspx